Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claim 39 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election of Species B (figs. 5-6) was made without traverse in the reply filed on 7/29/2026.
Claim Objections
Claim 34 is objected to because of the following informalities: “power lever” appearing in both line 3 and line 4 should read “power level”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 23 does not further limit the subject matter of claim 22, from which it depends, noting the last two lines of claim 22. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19, 21-24, 26-27, 29, 31, and 33-36 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Miller (US 2010/0069940). Miller discloses an ultrasonic instrument comprising:(a) a body (440; fig. 7); (b) an actuation assembly, wherein the actuation assembly comprises an activation member (450), wherein the activation member is operable to move along a range of motion relative to the body (along rails 452); (c) a shaft assembly (432) extending distally from the body, wherein the shaft assembly defines a longitudinal axis, wherein the shaft assembly comprises an acoustic waveguide; and (d) an end effector comprising an ultrasonic blade (430), wherein the ultrasonic blade is in acoustic communication with the acoustic waveguide, wherein the activation member is operable to activate the ultrasonic blade at a progressively increasing power level along a continuous range of power levels based on a position of the activation member along the range of motion relative to the body ([0088]-[0089]).
Regarding claim 21, the continuous range of power levels are proportional to the position of the activation member along the range of motion relative to the body ([0089]).
Regarding claims 22 and 23, the activation member is operable to activate the ultrasonic blade at a progressively increasing power level along a step-wise range of discrete power levels that is proportional to the position of the activation member along the range of motion relative to the body ([0089]).
Regarding claim 24, the end effector is configured to be activated in a first activation mode (e.g., “maximum”) in response to movement of the activation member in a first direction (direction in which button 450 is depressed as per [0089]) when the activation member is in a first position, wherein the end effector is configured to be activated in a second activation mode (e.g., “minimum”) in response to movement of the activation member in the first direction when the activation member is in a second position.
Regarding claim 26, the activation member comprises a button, wherein the button is configured to translate in a first direction (consider either direction of double ended arrow in fig 7) to select a mode of operation (e.g., select maximum or minimum; [0089]).
Regrading claim 27, the activation member is configured to select between a first mode of operation and a second mode of operation, wherein the end effector is configured to apply ultrasonic energy to tissue at a first power level (e.g., minimum) in the first mode of operation, and where the activation member is configured to apply ultrasonic energy to tissue at a second power level (e.g., maximum) in the second mode of operation ([0089]).
Regarding claim 29, the body includes a handle assembly (440 described as handpiece; [0085]).
Regarding claim 31, the activation member is configured to continuously and linearly increase power level along the continuous range of power levels based on the position of the activation member along the range of motion relative to the body ([0089]).
Regarding claim 33, Miller discloses that the device further comprises a visual indicator (e.g., slot formed by rails 452 and annular sections at proximal and distal ends of rails; see fig. 7) on the body, wherein the visual indicator is configured to provide visual feedback indicating a mode of operation selected through movement of the activation member. In particular, the user can see where the activation member is along the rails, thus giving a visual indication of the mode of operation (noting one end is associated with maximum power and the other is associated with minimum power)
Regarding claim 34, the visual indicator includes a display having a proximal display end and a distal display end, wherein the proximal display end is associated with a lower power level (level of zero), and wherein the distal display end is associated with a higher power level. See [0094]-[0095], wherein a distal-most position of activation slider 550 corresponds to the maximum level of ultrasonic energy. In this case, the display is considered the portion of the body over which the activation slider is free to translate, wherein the longitudinal position of 550 along the body 540 provides visual indication of the mode of operation (maximum versus power level of zero). Note that the embodiment of fig. 10 meets all of the limitations of claim 19, from which claim 34 depends.
Regarding claim 35, Miller discloses a tactile indicator operatively connected to the activation member, and configured to provide tactile feedback to an operator manipulating the activation member for indicating to the operator a selected power level from among the continuous range of power levels (see [0095]). Note that the embodiment of fig. 10 meets all of the limitations of claim 19, from which claim 35 depends.
Regarding claim 36, the tactile indicator includes a detent ([0095]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Weisenburgh, II et al. (US 2014/0135804). Miller discloses the invention substantially as stated above including an ultrasonic instrument with an activation member controlling ultrasonic actuation of the end effector, but fails to disclose that the activation member is configured to select between first and second modes of operation corresponding to application of ultrasonic energy and RF energy, respectively. However, Weisenburgh discloses another ultrasonic instrument, and further discloses that the ultrasonic instrument can be electrically connected to provide RF spot coagulation. Weisenburgh discloses that the device has an activation member (5074; fig. 78) configured to select between first and second modes of operation corresponding to application of ultrasonic energy and application of RF energy, respectively (see at least par. [0314]-[0316]). It would have been obvious to one skilled in the art to have modified the prior art of Miller to construct the ultrasonic instrument such that it can apply RF energy to tissue when the activation member selects a second mode of operation as taught by Weisenburgh in order to allow spot coagulation of tissue.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Price et al. (US 2014/0155921). Miller discloses the invention substantially as stated above including a handle assembly (440) meant to be grasped by a hand of an operator, but does not expressly disclose that the handle assembly has a pistol grip configured to be grasped by a hand of an operator.
Price discloses another ultrasonic instrument comprising a body including a handle assembly, a shaft assembly (110), an actuation assembly (132), and an end effector (112) comprising an ultrasonic blade. The handle assembly of Price includes a pistol grip (122; fig. 2) configured to be grasped by a hand of an operator. According to Price, the pistol grip has a proximal surface (128) that is optimized to fit the natural anatomical contours in the valley of the center of the palm and base of the thumb, while the saddle surface of the pistol grip provides a primary point of stability of the grip ([0126]). It would have been obvious one of ordinary skill in the art to have modified the handle assembly of the prior art of Miller to include a pistol grip as part of the handle assembly since such an arrangement is known as a suitable arrangement for a handle assembly of an ultrasonic instrument according to Price and advantageously provides a greater sense of stability, control, and comfort for the user according to Price.
Claim(s) 25 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Sartor et al. (US 2007/0093810). Miller discloses the invention substantially as stated above including an ultrasonic instrument with an activation member (450; fig. 7) that selects a mode of operation (intensity of the ultrasonic energy) by controlling electrical power ([0052]). Miller discloses that the activation member may take various forms (as illustrated in figs. 1-26) but fails to disclose that the activation member comprises a rotatable wheel configured to rotate about a rotational axis that is perpendicular to the longitudinal axis of the shaft assembly to select the mode of operation.
Sartor discloses another medical instrument having an activation member that allows the user to adjust the power level of the instrument. As an alternative to a slidable actuator (28/29a; fig. 1), Sartor discloses a rotatable wheel (329; fig. 13; [0094]-[0096]) configured to rotate about a rotational axis that is perpendicular to the longitudinal axis of the shaft assembly to select the mode of operation (i.e., power level). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Miller to include a rotatable wheel in place of the slidable button type actuator in view of the teachings of Sartor because such a modification can be considered a substitution of one known user-controlled actuator for adjusting the power level delivered to the surgical instrument for another wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Regarding claim 32, Miller discloses the invention substantially as stated above including an ultrasonic instrument with an activation member that allows for selection of continuously and linearly increasing power level along the continuous range of power levels ([0089]), but does not expressly disclose that the activation member is connected to a potentiometer.
Sartor discloses a medical instrument having an activation member that allows the user to adjust the power level of the instrument. Like activation member (450) of Miller, the activation member of Sartor may take the form of a slidable actuator (28/29a; fig. 1), the longitudinal position of the slidable actuator along the body of the device corresponding to the mode of operation (i.e., power level). Sartor discloses that the slidable actuator is connected to a potentiometer for continuously and linearly increasing power level along the continuous range of power levels ([0068]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Miller to include a potentiometer operatively connected to the activation member as taught by Sartor since Miller discloses that the device may include “a variable resistor, variable capacitor, variable inductor, and/or some other type(s) of circuit component(s)” that are “responsive to the longitudinal position of button assembly (450)”, Sartor discloses that potentiometers are known in the art for carrying out this function, and thus the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Claim(s) 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Stasz et al. (US 4,903,696) and Sartor et al. (US 2007/0093810). Regarding claim 37, Miller discloses an ultrasonic instrument including an ultrasonic instrument comprising: (a) a body including a handle assembly (440; fig. 7) configured to be grasped by a hand of an operator; (b) a shaft assembly (432) extending distally from the body, wherein the shaft assembly defines a longitudinal axis, wherein the shaft assembly comprises an acoustic waveguide; (c) an actuation assembly, wherein the actuation assembly comprises an activation member (450) that is operable to move along a range of motion relative to the body; and (d) an end effector comprising an ultrasonic blade (430), wherein the ultrasonic blade is in acoustic communication with the acoustic waveguide, wherein the activation member is operable to activate the ultrasonic blade at a progressively increasing power level along a continuous range of power levels based on a position of the activation member along the range of motion relative to the body ([0089]). The activation member is configured to continuously and linearly increase the power level along the continuous range of power levels ([0089]).
Miller fails to disclose that the activation member comprises a rotatable wheel, wherein the rotatable wheel is operable to move along a range of motion relative to the body, wherein the rotatable wheel is configured to rotate about a rotational axis that is perpendicular to the longitudinal axis of the shaft assembly; and wherein the rotatable wheel is operatively connected to a potentiometer for continuously and linearly increasing power level along the continuous range of power levels.
Stasz teaches that the power level of an ultrasonic instrument may be controlled via a rotatable wheel (knob 13) that is operatively connected to a potentiometer (58) (see col. 5, ll. 20-42; note knob 13 is rotatable to set power output as per col. 4, ll. 19-20). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Miller to replace the slidable button (450) forming the activation member of Miller with a rotatable wheel operatively connected to a potentiometer since such a modification can be considered a substitution of one known activation member that is movable to control the power level of an ultrasonic instrument for another wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success. Noting that the activation member of Miller is on the body of the handheld instrument, one skilled in the art would have found it obvious to incorporate the wheel and potentiometer combination taught by Stasz on the body of the ultrasonic instrument. However, Miller in view of Stasz does not expressly disclose that the rotatable wheel is configured to rotate about a rotational axis that is perpendicular to the longitudinal axis of the shaft assembly.
Sartor discloses another medical instrument having an activation member that allows the user to adjust the power level of the instrument. As an alternative to a slidable actuator (28/29a; fig. 1), Sartor discloses a rotatable wheel (329; fig. 13; [0094]-[0096]) placed on the instrument’s handle, the wheel configured to rotate about a rotational axis that is perpendicular to the longitudinal axis of the shaft assembly to select the mode of operation (i.e., power level). It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Miller to position the rotatable wheel of Miller as modified in view of Stasz on the body of the instrument such that the wheel is configured to rotate about a rotational axis perpendicular to the longitudinal axis of the shaft assembly as taught by Sartor since such placement of a rotating wheel used to adjust power level is known in the medical art and merely leads to the predictable result of a wheel that can be easily accessed and rotated by the user.
Regarding claim 38, it would have been obvious to provide the continuous range of power levels proportional to the position of the rotatable wheel along the range of motion (i.e., how much the wheel has been rotated) relative to the body of the prior art of Miller in view of Stasz and Sartor as this allows the user to be able to better estimate the level of power being applied based on the amount the user has turned the wheel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 3,755,900 to Friedman discloses wheel (24; figs. 1-2) connects to potentiometer (also numbered 24 by Friedman), wherein the wheel is mechanically ganged to the slider of the potentiometer to control the magnitude of the output voltage delivered to the tip of the instrument.
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KSH 8/27/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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